Zanitz by Zolutek GMC, S.A. de C.V.

Zanitz by

Drug Labeling and Warnings

Zanitz by is a Otc medication manufactured, distributed, or labeled by Zolutek GMC, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZANITZ- alcohol gel 
Zolutek GMC, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

To use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if skin irritation or rash appears and lasts. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to thoroughly cover your hands. Rubs hands together firmly until dry. No rinsing or towels needed. Not recomended for infants; for children under 6, use only with adult supervision.

Other information

  • Do not store above 110 °F (43°C).
  • May discolor certain fabrics

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, glycerin, hydrogen peroxide, isopropyl myristate, polypropylene glycol, tocopheryl acetate, water.

Package Label - Principal Display Panel

250 mL NDC: 79472-001-01

Zanitz

Package Label- Principal Display Panel

500 mL NDC: 79472-001-02

Zanitz

ZANITZ 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79472-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.02 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.9 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.18 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.8 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.013 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24.7 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79472-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/202001/24/2022
2NDC: 79472-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/202001/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/202001/24/2022
Labeler - Zolutek GMC, S.A. de C.V. (951578010)
Registrant - Zolutek GMC, S.A. de C.V. (951578010)
Establishment
NameAddressID/FEIBusiness Operations
Zolutek GMC, S.A. de C.V.951578010manufacture(79472-001)

Revised: 1/2022
 

Trademark Results [Zanitz]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZANITZ
ZANITZ
90208051 not registered Live/Pending
ZANITZ LLC
2020-09-24
ZANITZ
ZANITZ
90171672 not registered Live/Pending
RQJ'S LLC
2020-09-10

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